Recalls / Class II
Class IID-1219-2015
Product
Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.
- Affected lot / code info
- Lot#: 131954, 131955, Exp 08/31/2015
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 20,855 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-01
- FDA classified
- 2015-07-08
- Posted by FDA
- 2015-07-15
- Terminated
- 2017-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1219-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.